| Trial ID: | L4015 |
| Source ID: | NCT01607450
|
| Associated Drug: |
Glp-1 Low Dose
|
| Title: |
Modulation of Human Myocardial Metabolism by GLP-1 Dose Response
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01607450/results
|
| Conditions: |
Type 2 Diabetes Mellitus|Healthy
|
| Interventions: |
DRUG: GLP-1 Low Dose|DRUG: GLP-1 Mid-Range Dose|DRUG: GLP-1 High Dose|DRUG: Saline
|
| Outcome Measures: |
Primary: Myocardial Glucose Uptake., Myocardial glucose uptake measured using 18FDG PET, quantified using a 3-compartment model with a lumped constant of 1.0., After 12 hours of glucagon-like peptide 1 (GLP-1) exposure | Secondary: Myocardial Blood Flow, Myocardial perfusion derived from acetate kinetics, After 12 hours of GLP-1 exposure|Myocardial Total Oxidation Rate, MVO2 derived from acetate kinetics, After 12 hours of GLP-1 exposure|Cardiac Index, Impedance cardiography-derived measurement of cardiac index, assessed following 12 hour exposure to treatment condition concurrent with the PET measurements., After 12 hours of GLP-1 exposure|GLP-1 Concentrations, Achieved GLP-1 concentrations at the end of the 12 hour treatment exposure, After 12 hours of GLP-1 exposure
|
| Sponsor/Collaborators: |
Sponsor: Indiana University | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
33
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-05
|
| Completion Date: |
2012-12
|
| Results First Posted: |
2016-02-17
|
| Last Update Posted: |
2016-02-17
|
| Locations: |
Indiana Clinical Research Center, Indianapolis, Indiana, 46202, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01607450
|
